Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study (XIENCE V India)

13 de agosto de 2012 actualizado por: Abbott Medical Devices

XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-Arm Study

XIENCE V® India is a prospective, open-label, multi-center, observational, single-arm study to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Long term surveillance studies using a drug eluting stent (DES) may help elucidate mechanisms responsible for death, myocardial infarction, and late stent thrombosis risks not observed during controlled pre-market trials. This study will evaluate XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) performance in the "real world" when used by a broad group of physicians at a variety of health care facilities. Consequently, this protocol will include all consecutively enrolled patients in India who consent to participate and receive the XIENCE V® EECSS, which is expected to represent the range of clinical use during commercialization.

Adjunctive anti-platelet therapy is a critical factor in optimizing long term DES safety. Despite established guidelines that recommend 6-12 months dual antiplatelet therapy, patients with DES implants frequently stop taking their medication early. Consequently, XIENCE V® EECSS India Post-marketing Single-Arm Study (XIENCE V® India) follow-up will document patient adherence and persistence with adjunctive antiplatelet drug therapy at several time points throughout the study.

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval XIENCE V India study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the XIENCE V India study, from 5 years to after completion of the three year follow-up.

Tipo de estudio

De observación

Inscripción (Actual)

1000

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • India
      • Ahmedabad, India, 380054
        • Sal Hospital and Medical Institute
      • Amritsar, India
        • Escorts Heart & Superspeciality Institute Ltd.
      • Chennai, India, 600 037
        • Madras Medical Mission
      • Cochin, India
        • Lisie Heart Institute,Lisie Hosp.
      • Hyderabad, India, 500033
        • Apollo Hospital
      • Jaipur, India
        • Heart & General Hospital
      • Mumbai, India, 400050
        • Holy Family Hospital
      • New Delhi, India, 110025
        • Escorts Heart Institute & Research Centre
      • New Delhi, India, 110017
        • Max Devki Devi Heart & Vascular Institute
      • New Delhi, India, 110 070
        • Escorts Heart Institute & Research Centre
      • New Delhi, India, 110 070
        • Fortis Hospital
      • Pune, India, 411030
        • Poona hospital and research centre
      • Pune, India, 411001
        • Jehangir Hospital
    • Andhra Pradesh
      • Hyderabaad, Andhra Pradesh, India, 500034
        • Care hospital
      • Hyderabad, Andhra Pradesh, India, 5000003
        • Krishna Heart Institute,
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 006
        • Krishna Heart Institute
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College & Hospital
    • Tamilnadu
      • Vellore, Tamilnadu, India, 632004
        • Christian Medical Center (CMC)

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

The group will be all consecutively enrolled patients in India treated by a broad group of physicians at a variety of health care facilities, who consent to participate and receive the XIENCE V® EECSS, which is expected to represent the range of clinical use during commercialization.

Descripción

Inclusion Criteria:

  • The patient agrees to participate in this study by signing the EC approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.

Exclusion Criteria:

  • The inability to obtain an informed consent is an exclusion criterion.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
1
The group will be monitored to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Dispositivo: XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease
Otros nombres:
  • Sistema de stent coronario liberador de everolimus XIENCE V®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Stent thrombosis rates as defined by Academic Research Consortium (ARC)
Periodo de tiempo: Annually through to 3 years
Annually through to 3 years
Composite endpoint of cardiac death and myocardial infarction (MI)
Periodo de tiempo: at 1 year
at 1 year

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Composite rate of cardiac death and any MI (Q-wave and non Q-wave)
Periodo de tiempo: at 30, 180 days and at 2 and 3 years
at 30, 180 days and at 2 and 3 years
Composite rate of all death and any MI (Q-wave and non Q-wave)
Periodo de tiempo: at 30, 180 days and at 2 and 3 years
at 30, 180 days and at 2 and 3 years
Composite rate of cardiac death , any MI (Q-wave and non Q-wave) attributed to the target vessel, and target lesion revascularization (PCI and CABG)
Periodo de tiempo: at 30, 180 days and at 2 and 3 years
at 30, 180 days and at 2 and 3 years
Death (cardiac death, vascular death, and non-cardiovascular death)
Periodo de tiempo: at 30, 180 days and at 2 and 3 years
at 30, 180 days and at 2 and 3 years
Any MI (Q-wave and non Q-wave)
Periodo de tiempo: at 30, 180 days and at 2 and 3 years
at 30, 180 days and at 2 and 3 years
Major bleeding complications
Periodo de tiempo: at 14, 30, 180 days and at 1, 2 and 3 years
at 14, 30, 180 days and at 1, 2 and 3 years
Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
Periodo de tiempo: at 14, 30, 180 days and at 1, 2 and 3 years
at 14, 30, 180 days and at 1, 2 and 3 years
Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG)
Periodo de tiempo: at 30, 180 days and at 1, 2 and 3 years
at 30, 180 days and at 1, 2 and 3 years
Clinical device and procedural success
Periodo de tiempo: Acute
Acute
Patient health status (symptoms, physical function, and quality of life) assessed by the Seattle Angina Questionnaire
Periodo de tiempo: at baseline, 180 days, and 1 year
at baseline, 180 days, and 1 year
Stent thrombosis
Periodo de tiempo: 24 hours (acute) and 30 days (sub-acute)
24 hours (acute) and 30 days (sub-acute)
Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization (PCI and CABG)
Periodo de tiempo: 30, 180 days and 1, 2 and 3 years
30, 180 days and 1, 2 and 3 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Abbott Medical Devices

Investigadores

  • Investigador principal: Ashok Seth, MD, Max Devki Devi Heart & Vascular Institute
  • Investigador principal: Tejas Patel, MD, Krishna Heart Institute

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2008

Finalización primaria (Actual)

1 de abril de 2010

Finalización del estudio (Actual)

1 de agosto de 2012

Fechas de registro del estudio

Enviado por primera vez

28 de febrero de 2008

Primero enviado que cumplió con los criterios de control de calidad

6 de marzo de 2008

Publicado por primera vez (Estimar)

7 de marzo de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

14 de agosto de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

13 de agosto de 2012

Última verificación

1 de agosto de 2012

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 07-378
  • REFCTRI000213, 21-10-2008 (Identificador de registro: Clinical Trials Registry - India)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir